Health regulator stops approving Section 21 medicine applications
Lawyer Ricky Stone says the South African Health Products Regulatory Authority has refused every new Section 21 application since July, leaving medical cannabis patients unsure how to get treatment. He says the regulator gave no public reason.
Section 21 of the Medicines Act lets patients get unregistered medicines, including cannabis-based medicines. Stone works at Cullinan & Associates and represents people who used this route to reach medical cannabis. He said hundreds, if not thousands, of applications were submitted.
Stone said a blanket refusal raises serious legal questions. He said the regulator must still consider each application, think about it and make a rational decision. In his view, patients and their doctors may have grounds to challenge rejections in court.
Stone also said Section 21 has been largely abused and has become an easy route to cannabis. He spoke in an interview with a CapeTalk presenter. The regulator has not commented in the facts available.
Key facts
- Who
- Ricky Stone (lawyer at Cullinan & Associates representing people who have accessed medical…); John Maytham (CapeTalk presenter who interviewed Stone); South African Health Products Regulatory Authority (health regulator refusing new Section 21 applications)
- What
- The South African Health Products Regulatory Authority has stopped approving new Section 21 applications for unregistered medicines, which raises uncertainty for medical cannabis patients. Ricky Stone of Cullinan & Associates says a blanket refusal raises serious legal questions and that patients and doctors may have grounds to challenge rejections in court.
- When
- 4 November 2026
- Where
- South Africa
- Status
- Reported